A Clinical Study of GZR33 and GZR101 in Healthy Subjects

Phase Ib Clinical Study on the Safety, Tolerance, Pharmacokinetics, and Pharmacodynamics of GZR33 and GZR101 in Healthy Adult Male Subjects

This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjects.This study consists of Part A and Part B.

Part A is a randomized, open-label, single-dose, two-sequence, two-period, cross-over design comparative study evaluating the PD and PK characteristics of GZR33 and Insulin Degludec Injection.

Part B is a randomized, double-blind, placebo-controlled, multiple-dose, parallel-group design study evaluating the safety, tolerability, immunogenicity, and PK of GZR33 and GZR101.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: GZR33 Injection; Drug: Insulin Degludec; Drug: GZR101 Injection; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hebei
    • Xingtai, Hebei, China
      • Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. Voluntarily participated in the study and signed the informed consent form (ICF);
• 2.Chinese healthy male adult subjects aged 18-45 years old (including 18 and 45 years old as of the date of signing the ICF);
• 3.During screening period, the body mass index (BMI) between 19.0 and 24.0 kg/m2, inclusive, and a body weight>50 kg (not containing 50kg).

Exclusion Criteria:

• 1.History of drug abuse within one year prior to screening.
• 2.History of alcohol abuse within 6 months prior to screening (alcohol abuse is defined as more than 14 units weekly: 1 unit of alcohol equals to 360 mL of beer, 150 mL of wine, or 45 mL of 40% alcohol).The subject who smoke more than 5 cigarettes per day within 3 months prior to screening, smoke within 48 h prior to the use of the investigational drug, and is unwilling to refrain from smoking and drinking during the trial period.
• 3.Allergic constitution, or history of bronchial asthma, hives, eczema and other allergic diseases (except mild asymptomatic seasonal allergy), or known allergy to the investigational drug or its excipients, hypersensitivity or intolerance.
• 4.Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, syphilis spiral test or human immunodeficiency virus (HIV) antibodies positive.
• 5.History of needle and blood sickness, and subject couldn't tolerate venipuncture for blood collection, or be difficult to collect blood.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A; Part A : randomized, open-label, single-dose, two-sequence, two-period, cross-over Single administration of GZR33, washout period of 14 days, followed by single administration of Insulin Degludec Single administration of Insulin Degludec, washout period of 14 days, followed by single administration of GZR33	Drug: GZR33 Injection; Administered as once daily subcutaneous dose; Drug: Insulin Degludec; Administered as once daily subcutaneous dose
Experimental: Part B; Part B: randomized, double-blind, placebo-controlled, multiple-dose, parallel Drug: GZR33 Injection Participants will receive once daily GZR33 Injection or placebo for 6 days, s.c. Drug: GZR101 Injection Participants will receive once daily GZR101 Injection or placebo for 6 days, s.c.	Drug: GZR33 Injection; Administered as once daily subcutaneous dose; Drug: GZR101 Injection; Administered as once daily subcutaneous dose; Drug: Placebo; Administered as once daily subcutaneous dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-24h	Area under the plasma concentration-time curve from time 0 to 24 hours	From 0 to 24 hours
Incidence of adverse events (AE)	Any changes or abnormal results in the following safety variables: incidence of adverse events (AE), including but not limited to hypoglycemic reactions, injection site reactions, clinical laboratory tests, 12-lead ECG, vital signs, physical examination, and local tolerability at the injection site.	From Predose to Day12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentration	From Predose to Day7
tmax	Time to reach maximum plasma concentration	From Predose to Day7
AUC0-last	Area under the plasma concentration-time curve from time 0 to the last blood sampling time point	From Predose to Day7

Collaborators and Investigators

• Sponsor: Gan and Lee Pharmaceuticals, USA
• Investigators: Study Director: Clinical Transparency, Gan&Lee Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2022
• Primary Completion (Actual): February 3, 2023
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: GL-GZR-CH1013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No